EU plans new rules – but lacks solid facts
24th Apr 2026
The European Commission is preparing the next major step in Europe’s tobacco and nicotine policy. The new rules are meant to be based on an evaluation of the Tobacco Products Directive (TPD). However, the Commission now admits that the foundation for this work is incomplete and weak.
Because around a dozen EU member states failed to provide key information on the administrative burden of the TPD, the Commission chose to draw conclusions for the entire EU using statistical estimates. As a result, the analysis of Europe’s nicotine market is in practice based on data from just over half of the member states.
For rules that could affect millions of consumers and decide the future of smoke‑free alternatives, this is a serious problem.
EU’s own criticism: “Insufficient evidence”
The criticism does not come only from external stakeholders. The European Commission’s own review body, the Regulatory Scrutiny Board, has issued a negative opinion on the evaluation. Its message is clear: the analysis is too narrow and the evidence base too weak to support far‑reaching new regulation.
Despite this, the report is now being used as the starting point for the next version of the Tobacco Products Directive, often referred to as TPD3.
“When adjusting rules that affect public health, consumer choice and markets across Europe, you cannot make political decisions based on half the picture,” says Markus Lindblad, Communications Manager at Pouch Patrol.
Risk of false equivalence – everything treated like cigarettes
At the heart of the criticism is how the EU risks handling smoke‑free nicotine products. Instead of recognising differences in risk between products, there is a clear tendency to treat all nicotine in the same way.
“There is well‑documented evidence that smoking is far more harmful than using smoke‑free alternatives. Yet there is a real risk that future rules will ignore this and lump everything together,” Lindblad says.
This could mean that products like nicotine pouches and other smoke‑free alternatives are regulated in the same way as cigarettes – even though they involve no combustion and therefore do not carry the same health risks.
Sweden ignored – despite clear results
Internationally, Sweden is often highlighted as an exception in Europe, with the EU’s lowest smoking rates. A key reason is the shift from cigarettes to smoke‑free nicotine products.
Against this background, it is especially concerning if future EU regulation is developed without taking national experience and real‑world outcomes into account.
“Sweden shows that proportionate regulation of smoke‑free products can help reduce smoking. That should be something to build on – not something to ignore,” says Lindblad.
TPD3: a crossroads for the EU
The current evaluation does not introduce new rules by itself. But it lays the groundwork for TPD3, which may determine how nicotine pouches, vapes and other smoke‑free nicotine products can be sold, taxed and regulated in the future.
If the EU is serious about evidence‑based regulation, it now needs complete and comparable data, transparent methods, and clear distinctions between products with different risk profiles.
Otherwise, EU nicotine policy risks missing its target. Instead of accelerating the shift away from cigarettes, it may slow it down.
“Rules that do not reflect reality risk harming both consumers and public health,” Markus Lindblad concludes.
